PUBLIC HEALTH EFFECTIVENESS OF THE FDA 510(k) CLEARANCE PROCESS
Measuring Postmarket Performance and Other Select Topics
Workshop Report
Theresa Wizemann, Editor
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington D.C.
www.nap.edu
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This project was supported by a contract between the National Academy of Sciences and the US Department of Health and Human Services (HHSF223200810020I, TO 13). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the agency that provided support for this project.
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Suggested citation: IOM (Institute of Medicine). 2011. Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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COMMITTEE ON THE PUBLIC HEALTH EFFECTIVENESS OF THE FDA 510(k) CLEARANCE PROCESS1
DAVID CHALLONER (Chair), Vice President for Health Affairs,
Emeritus, University of Florida, Gainesville, FL
GARY S. DORFMAN, Professor and Vice Chair for Research,
Weill Cornell Medical College, New York, NY
BARBARA EVANS, Associate Professor; Codirector,
Health Law & Policy Institute;
Director,
Center on Biotechnology and Law, University of Houston Law Center, Houston, TX
LAZAR GREENFIELD, Professor of Surgery and Chair Emeritus,
University of Michigan, Ann Arbor, MI
STEVEN GUTMAN, Associate Director,
BlueCross BlueShield Assocation, Alexandria, VA
YUSUF M. KHAN, Assistant Professor,
University of Connecticut Health Center, Farmington, CT
DAVID KORN, Vice Provost for Research,
Harvard University, Boston, MA
ELIZABETH W. PAXTON, Director of Surgical Outcomes and Analysis,
Kaiser Permanente, San Diego, CA
SHARI LAWRENCE PFLEEGER, Director of Research,
Institute for Information Infrastructure Protection, Washington, DC
WILLIAM W. VODRA, Senior Counsel (Retired),
Arnold & Porter, LLP, Washington, DC
BRIAN WOLFMAN, Visiting Professor of Law,
Georgetown University Law Center, Washington, DC
KATHRYN C. ZOON, Scientific Director and Director of the Division of Intramural Research,
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
Study Staff
ABIGAIL E. MITCHELL, Study Director
HEATHER M. COLVIN, Program Officer
KATHLEEN M. McGRAW, Senior Program Assistant
NORMAN GROSSBLATT, Senior Editor
ROSE MARIE MARTINEZ, Director,
Board on Population Health and Public Health Practice
Reviewers
This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We thank the following for their review of this report:
Richard DeRisio, Abbott Medical Optics
Larry Kessler, School of Public Health, University of Washington
John S. Rumsfeld, Veterans Health Administration
Terrence J. Sweeney, Philips Healthcare
Susan F. Wood, School of Public Health and Health Services, The George Washington University
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of the report was overseen by Kristine M. Gebbie, Acting Joan Grabe Dean of the School of Nursing, Hunter College at the City University of New York. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests with the authors and the institution.
TABLES, FIGURES, AND BOXES
Tables
2-1 |
Primary Reason for 118 Class I Recalls |
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C-1 |
Number of Recalls per 510(k) |
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C-2 |
Causes of 510(k) Recalls |
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C-3 |
Medical Device Reporting and 510(k)s |
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D-1 |
Examples of Adverse Events Where Medical Device Software Played a Significant Role |
Figures
2-1 |
Breakdown of advisory-committee assignments for 510(k) submissions in 1996–2009 |
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3-1 |
Statistical methods used in the DELTA System |
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3-2 |
Prospective DELTA Network Study |
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C-1 |
Annual number of 510(k) applications |
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C-2 |
Advisory committee assignments for submitted 510(k)s |
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C-3 |
510(k) device classification |
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C-4 |
510(k) type, 1996–2009 |
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C-5 |
510(k) implantable and life-sustaining features, 2003–2009 |
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C-6 |
Annual number of unique 510(k)s affected by recall |
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C-7 |
Year of 510(k) decision for recalls occurring in 2003–2009 |
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C-8 |
Recall-free 510(k) “survival,” 2003–2009 |
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C-9 |
Annual 510(k) recall rate based on years since decision |
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C-10 |
Impact of predicate number on 510(k) recalls, 2004–2009 |
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C-11 |
Impact of predicate age on 510(k) recalls, 2004–2009 |
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C-12 |
Impact of 510(k) type on recall rate, 2003–2009 |
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C-13 |
Association of 510(k) features with recall rate, 2003–2009 |
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C-14 |
Device classification and 510(k) recall rate, 2003–2009 |
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C-15 |
Association of advisory committee assignments with 510(k) recall rate, 2003–2009 |
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C-16 |
Medical device reporting and recalls |
Boxes
1-1 |
IOM Study on the Public Health Effectiveness of the FDA 510(k) Clearance Process |
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1-2 |
Definitions of Medical Device Classes |
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2-1 |
Types of Device Hazards |
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2-2 |
Maisel’s Key Findings: Analysis of FDA Recall Data |
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2-3 |
Hall’s Key Findings: Using Recall Data to Assess the 510(k) Process |
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3-1 |
NCDR Registries |
Abbreviations
AED automatic external defibrillator
CART Clinical Assessment, Reporting, and Tracking program
CDRH Center for Devices and Radiological Health (FDA)
CE Mark European conformity mark
CHMP Committee for Human Medicinal Products
CMS Centers for Medicare and Medicaid Services
EMA European Medicines Agency
FDA US Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
GHTF Global Harmonization Task Force
GRAE generally recognized as effective
GRAS generally recognized as safe
ICD implantable cardioverter–defibrillator
IDE investigational device exemption
ISO International Organization for Standardization
MAUDE Manufacturer and User Facility Device Experience Database
MDA Medical Device Amendments of 1976
MDR medical-device reporting